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Comprehensive and up-to-date drug news for both consumers and healthcare professionals.

Health Highlights: Nov. 16, 2018

Posted yesterday in Medical

Here are some of the latest health and medical news developments, compiled by the editors of HealthDay: More Raw Turkey Products Recalled More than 91,000 pounds of raw turkey products from Jennie-O Turkey Store Sales, LLC have been recalled after some products tested positive for a salmonella strain associated with an outbreak linked to raw turkey products, the U.S. Department of Agriculture's Food Safety and... Read more

For Kids' Sports, Diversification Is Best

Posted today in Medical

SATURDAY, Nov. 17, 2018 -- If your kid is highly skilled at hockey but wants to try basketball, new research suggests you shouldn't worry about whether that might cost your child a college scholarship. Researchers surveyed 91 professional and collegiate ice hockey players and found they tended to play multiple sports as children, and only started to focus solely on hockey at about age 14. "In many sports, there's a... Read more

FDA Approves Adcetris (brentuximab vedotin) in Combination with Chemotherapy for Adults with Previously Untreated Systemic Anaplastic Large Cell Lymphoma or Other CD30-Expressing Peripheral T-Cell Lymphomas

Posted today in New Drug Approvals

BOTHELL, Wash.--(BUSINESS WIRE)--Nov. 16, 2018-- Seattle Genetics, Inc. (Nasdaq:SGEN) today announced a new approval for Adcetris (brentuximab vedotin) in combination with CHP chemotherapy (cyclophosphamide, doxorubicin, prednisone) from the U.S. Food and Drug Administration (FDA) for adults with previously untreated systemic anaplastic large cell lymphoma (sALCL) or other CD30-expressing peripheral T-cell lymphomas... Read more

AAP Updates Management of Sport-Related Concussion

Posted today in News for Health Professionals

FRIDAY, Nov. 14, 2018 -- Recommendations have been developed for the diagnosis and management of pediatric sport-related concussion (SRC), according to a clinical report published online Nov. 12 in Pediatrics. Mark E. Halstead, M.D., from the Washington University School of Medicine in St. Louis, and colleagues updated the 2010 American Academy of Pediatrics clinical report on the current state of knowledge and... Read more

Epinephrine Personal Autoinjectors Cost-Effective at $24

Posted today in News for Health Professionals

FRIDAY, Nov. 16, 2018 -- In a simulation of children with peanut allergy, epinephrine personal autoinjectors are cost-effective at $24, according to a study published online Nov. 16 in JAMA Network Open. Marcus Shaker, M.D., from the Dartmouth-Hitchcock Medical Center in Lebanon, New Hampshire, and Matthew Greenhawt, M.D., from the University of Colorado School of Medicine in Aurora, assessed cost ceilings for... Read more

CDC: Increase Seen in Salmonella Illnesses From Ground Beef

Posted today in News for Health Professionals

FRIDAY, Nov. 16, 2018 -- There have been 126 more cases of illness added to an investigation into a Salmonella outbreak linked to recalled ground beef products from JBS Tolleson Inc., bringing the total to 246 cases in 25 states, the U.S. Centers for Disease Control and Prevention says. Illnesses began between Aug. 5, 2018, and Oct. 16, 2018, and 59 people have been hospitalized. No deaths have been reported, the... Read more

Burden of Liver Cancer Rising in Medicare Patients

Posted today in News for Health Professionals

FRIDAY, Nov. 16, 2018 -- Both hospitalizations and deaths are increasing among Medicare recipients with liver cancer, according to a study presented at The Liver Meeting, the annual meeting of the American Association for the Study of Liver Diseases, held from Nov. 9 to 13 in San Francisco. Omer Shahab, M.D., from Inova Fairfax Hospital in Falls Church, Virginia, and colleagues used ICD-9 codes among a random sample... Read more

Climate Change Expected to Lead to Rise in Lyme Disease

Posted today in News for Health Professionals

FRIDAY, Nov. 16, 2018 -- Rising temperatures are expected to increase the number of cases of Lyme disease in the United States by more than 20 percent by mid-century, according to a study published online Oct. 24 in the Canadian Journal of Infectious Diseases and Medical Microbiology. Igor Dumic, M.D., from the Mayo Clinic in Rochester, Minnesota, and Edson Severnini, Ph.D., from Carnegie Mellon University in... Read more

Vapers May Prompt Smokers to Quit: Study

Posted today in Medical

FRIDAY, Nov. 16, 2018 -- Could vapers be a good influence on smokers? New research suggests that's so: Cigarette smokers who spent more time with people who used electronic cigarettes were more likely to try quitting smoking. The study included more than 13,000 smokers in England. Of those, nearly 26 percent said they regularly spent time with e-cigarette users. Among that group, about 32 percent made an attempt to... Read more

AHA: Warm, Wet Weather Linked to Better Outcomes for Stroke Survivors

Posted yesterday in Medical

FRIDAY, Nov. 16, 2018 (American Heart Association) -- Rainy days may bring a lot more than relief from summer heat -- they also are connected to better survival chances and overall outlook for stroke survivors, according to a new study. Researchers examining the connection between strokes and seasonal weather in the United States found that hospital admissions for ischemic strokes, those caused by blood clots, went... Read more

Under New Plan, FDA Hopes to Cut Use of Dogs in Veterinary Drug Trials

Posted yesterday in Medical

FRIDAY, Nov. 16, 2018 -- As part of a new effort to cut the use of dogs in drug trials, the U.S. Food and Drug Administration on Friday launched an initiative to keep canines out of studies for certain veterinary medicines. The project is aimed at "bioequivalence" trials -- studies conducted to test whether a new generic version of a drug is equivalent in effectiveness and safety to an existing medicine. Often,... Read more

Lilly Submits New Drug Application to the FDA for Lasmiditan for Acute Treatment of Migraine

Posted 3 days ago in New Drug Applications

INDIANAPOLIS, Nov. 14, 2018 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) has announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for lasmiditan for the acute treatment of migraine with or without aura in adults. Lasmiditan is an investigational, oral, centrally-penetrant, selective serotonin 5-HT1F agonist that is structurally and mechanistically distinct... Read more

FDA Approves Yupelri (revefenacin) for Chronic Obstructive Pulmonary Disease (COPD)

Posted 7 days ago in New Drug Approvals

DUBLIN, Ireland, HERTFORDSHIRE, England and PITTSBURGH, Nov. 9, 2018 /PRNewswire/ -- Theravance Biopharma, Inc. (NASDAQ: TBPH) ("Theravance Biopharma") and Mylan N.V. (NASDAQ: MYL) ("Mylan") today announced that the U.S. Food and Drug Administration (FDA) has approved the  New Drug Application (NDA) for Yupelri (revefenacin) inhalation solution for the maintenance treatment of patients with... Read more

FDA Approves Keytruda (pembrolizumab) for the Treatment of Patients with Hepatocellular Carcinoma (HCC) Who Have Been Previously Treated with Sorafenib

Posted 8 days ago in New Drug Approvals

KENILWORTH, N.J.--(BUSINESS WIRE) November 9, 2018 --Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved Keytruda, Merck’s anti-PD-1 therapy, for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. This indication is approved under accelerated approval based... Read more

FDA Approves Newly Formulated OTC Primatene Mist (epinephrine) to Treat Mild Asthma

Posted 9 days ago in New Drug Approvals

RANCHO CUCAMONGA, Calif., Nov. 07, 2018 (GLOBE NEWSWIRE) -- Amphastar Pharmaceuticals, Inc., (NASDAQ: AMPH) announced today that the U.S. Food and Drug Administration (FDA) granted approval of its New Drug Application (NDA) for Primatene Mist (epinephrine inhalation aerosol bronchodilator suspension), which is delivered by a metered dose inhaler (MDI) with a non-chlorofluorocarbon (CFC) propellant. Primatene Mist is... Read more

Bausch Health Announces U.S. Launch of Bryhali (halobetasol propionate) Lotion, 0.01%, for Plaque Psoriasis In Adults

Posted 9 days ago in New Drug Approvals

LAVAL, Quebec, Nov. 7, 2018 /PRNewswire/ -- Bausch Health Companies Inc. (NYSE/TSX: BHC) and its dermatology business, Ortho Dermatologics, one of the largest prescription dermatology health care businesses, today announced it expects to start distribution of Bryhali (halobetsasol propionate) Lotion, 0.01%, to U.S. wholesale pharmaceutical distributors later this month. The company received final approval from the... Read more

Trevena Receives Complete Response Letter for Oliceridine from FDA

Posted 2 weeks ago in New Drug Applications

November 2, 2018 -- Trevena, Inc. (NASDAQ: TRVN) today announced the Company has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for oliceridine. “While we are disappointed with FDA’s decision, we continue to believe in the strength of the data and the ultimate approvability of oliceridine,” said Carrie L. Bourdow,... Read more

Sage Therapeutics Announces FDA Advisory Committee Votes 17-1 in Support of Benefit-Risk Profile of Zulresso (brexanolone) Injection for Treatment of Postpartum Depression

Posted 2 weeks ago in New Drug Applications

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Nov. 2, 2018-- Sage Therapeutics (NASDAQ: SAGE), a clinical-stage biopharmaceutical company developing novel medicines to treat life-altering central nervous system (CNS) disorders, today announced that the U.S. Food and Drug Administration (FDA) Psychopharmacologic Drugs Advisory Committee (PDAC) and Drug Safety and Risk Management Advisory Committee (DSaRM) jointly voted (17 yes,... Read more

Alkermes Reports on Outcome of FDA Advisory Committee Meeting on ALKS 5461 for the Adjunctive Treatment of Major Depressive Disorder

Posted 2 weeks ago in New Drug Applications

DUBLIN, Nov. 1, 2018 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS) today announced that the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee, appointed by the U.S. Food and Drug Administration (FDA), met to review the company's New Drug Application (NDA) for ALKS 5461. The committee jointly voted that the benefit-risk profile was not adequate to support... Read more

Heron Announces FDA Submission of HTX-011 NDA for Postoperative Pain Management

Posted 2 weeks ago in New Drug Applications

SAN DIEGO, Oct. 31, 2018 /PRNewswire/ -- Heron Therapeutics, Inc. (Nasdaq: HRTX), a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments to address some of the most important unmet patient needs, today announced the submission of its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for HTX-011. HTX-011 is an investigational,... Read more

Attenua Announces First Patient Treated in Phase 2 Clinical Trial in Chronic Cough with Bradanicline

Posted 2 days ago in Clinical Trials

San Mateo, Calif, Nov 14, 2018 – Attenua, Inc., a clinical-stage biopharmaceutical company focused on developing novel medicines to treat cough, today announced that the first patient has been treated in a Phase 2 clinical trial in chronic cough with bradanicline (formerly known as ATA-101), its lead compound. “Within just six months of our initial Series A funding, Attenua has successfully filed an... Read more

Entasis Therapeutics Announces Zoliflodacin Phase 2 Results Published in The New England Journal of Medicine

Posted 9 days ago in Clinical Trials

WALTHAM, Mass., Nov. 07, 2018 (GLOBE NEWSWIRE) -- Entasis Therapeutics (NASDAQ: ETTX), a clinical-stage biopharmaceutical company focused on the discovery and development of novel antibacterial products, announced that The New England journal of Medicine (NEJM) published results from a Phase 2 clinical trial evaluating the safety and efficacy of zoliflodacin in patients with uncomplicated gonorrhea. Zoliflodacin... Read more

Janssen Reports Positive Topline Results for FLAIR Phase 3 Study of a Novel, Long Acting Injectable Two-Drug Regimen for the treatment of HIV-1

Posted 2 weeks ago in Clinical Trials

CORK, IRELAND, October 31, 2018 – The Janssen Pharmaceutical Companies of Johnson & Johnson today confirmed positive topline results from the global, Phase 3 FLAIR (First Long-Acting Injectable Regimen) study of a long-acting, injectable two-drug regimen (2DR) for the treatment of HIV. The study, conducted by ViiV Healthcare, showed long-acting rilpivirine and cabotegravir, injected once a month, had... Read more

Two-year data for Novartis brolucizumab reaffirm superiority versus aflibercept in reducing retinal fluid in patients with nAMD

Posted 2 weeks ago in Clinical Trials

Basel, 27 October, 2018 - Novartis announced additional brolucizumab Phase III results from year two that reaffirmed its positive year one findings. Brolucizumab met its primary endpoint of non-inferiority versus aflibercept in best corrected visual acuity (BCVA) and exhibited superiority in key retinal outcomes at year one (48 weeks)[1],[2]. Secondary endpoints at year two (96 weeks) reaffirmed superiority of... Read more

New STAIRWAY Study Data Shows Potential for Extended Durability With Faricimab in Wet Age-Related Macular Degeneration (AMD)

Posted 2 weeks ago in Clinical Trials

South San Francisco, CA -- October 27, 2018 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced positive results from the Phase II STAIRWAY study which explored the extended durability of faricimab (RG7716) in the treatment of wet age-related macular degeneration (AMD), a leading cause of blindness in people aged 60 and over in the United States.3 At 52 weeks, faricimab patients... Read more